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Ironjustic
Wed, Aug-15-07, 06:15
Anyone care to guess WHY there were NO .. deaths .. ?
Where did they hide the bodies .. ? There HAD to be ..
some .. bodies.

The Acord Study seemed to be following the steps of the
Procrit study in which Procrit had 33% increased .. death ..
which has led to the veritable **demise** of .. Amgen ..
Procrit was their .. lifeblood.

NOW this Acord Study is completed .. using another epoetin ..
BUT .. **noone** dies .. NO .. increased .. DEATH .. ?

Same .. investigational target hemoglobin level of 13.5 grams
per deciliter of blood (g/dL).

The Acord Study compared to the Choir Study. Choir
Study:1,432 patients 72 died at 13.5 g/dL and 56 died at 11.3
g/ dL Acord Study:172 patients - 0? died at 13.5 g/dL and 0?
died at 11.3 g/
dL .. ? According to calculation: - 7 died at 13.5 g/dl and 5
died at 11.3 g/
DLI .. ?

This would because of the small study .. and therefore
any real ability to say .. "see" / not enough dead
bodies TO count.

Procrit made the mistake of BEING the brunt OF .. a ..
large .. study.

<<snip>> There were no clinically relevant differences in
adverse events between study groups. {Acord Study } <<snip>>

Two .. people .. not really significant .. multiply that by ..
thousands ..

BUSINESS/FINANCIAL DESK Heart Risk Seen in Drug For Anemia
November 16, 2006 Health News By ALEX BERENSON A new study
suggests that high doses of a best-selling drug used to treat
anemia in dialysis and cancer patients may increase the risk
of heart problems.

--------------------------------------------

Ortho Biotech Products, L.P. Release: Data From Correction Of
Hemoglobin And Outcomes In Renal Insufficiency (CHOIR) Study
Presented At National Kidney Foundation Meeting

CHICAGO, April 20 /PRNewswire/ -- Final data from an
investigational clinical trial, Correction of Hemoglobin and
Outcomes in Renal Insufficiency, referred to as the CHOIR
study, were presented today at the National Kidney Foundation
(NKF) 2006 Spring Clinical Meetings.

The primary analysis of the composite endpoint showed a
statistically significant higher incidence of composite
endpoint events -- consisting of mortality, stroke, heart
attack and hospitalization due to congestive heart failure --
in the group of patients treated to the investigational
hemoglobin target of 13.5 g/dL, as compared to the group
treated to the hemoglobin target that is consistent with the
current product label, 11.3 g/dL.

One hundred and twenty-eight patients died during the study
and the 90-day study follow-up period: 72 patients in the arm
being treated to 13.5 g/dL and 56 patients in the arm being
treated to 11.3 g/dL

http://topics.nytimes.com/top/reference/timestopics/organizat-
ions/h/harvard= _university/index.html?query=3DEPOETIN%20(DRU-
G)&field=3Ddes&match=3Dexact

The Anaemia CORrection in Diabetes (ACORD) study aims to
investigate the effects of early anaemia correction with
subcutaneous NeoRecormon=C2=AE (epoetinbeta) on cardiac
structure and function in patients with early diabetic
nephropathy. The ACORD study is an international
multicentre,randomised trial in which diabetic patients who
are anaemic (Hb =E2=89=A5 10.5g/dl but less than 13g/dl) are
assigned to one of two treatment groups. The early anaemia
correction group start epoetinbeta therapy immediately to
attain a target Hb level of 13=E2=80=931=
5g/dl, while the late anaemia correction group only begin
treatment once their Hb has declined below 10.5g/dl, with a
target level of 10.5=E2=80=93
11.5g/dl. The results from the ACORD and IRIDIEM trials will
provide additional information regarding the optimal
management of anaemia and risk factors in patients
with early diabetic nephropathy. Early referral and
individualised intervention of patients with
diabetic nephropathy is likely to be essential in
order to minimise morbidity and mortality.

<<snip>> There were no clinically relevant differences in
adverse events between study groups. <<snip>>

Am J Kidney Dis. 2007 Feb;49(2):194-207. Links Erratum in: Am
J Kidney Dis. 2007 Apr;49(4):562. Target level for hemoglobin
correction in patients with diabetes and CKD: primary results
of the Anemia Correction in Diabetes (ACORD) Study.Ritz E,
Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de
Alvaro F; Anemia Correction in Diabetes Study Investigators.
Department of Internal Medicine, University of Heidelberg;
Medical Clinic I, University Hospital Mannheim, Germany.
prof.e.ritz@t- online.de

BACKGROUND: Patients with diabetes and anemia are at high risk
of cardiovascular disease. The Anemia CORrection in Diabetes
(ACORD) Study aimed to investigate the effect of anemia
correction on cardiac structure, function, and outcomes in
patients with diabetes with anemia and early diabetic
nephropathy. METHODS: One hundred seventy-two patients with
type 1 or 2 diabetes mellitus, mild to moderate anemia, and
stage 1 to 3 chronic kidney disease were randomly assigned to
attain a target hemoglobin (Hb) level of either 13 to 15 g/dL
(130 to 150 g/L; group 1) or 10.5 to 11.5 g/dL (105 to 115
g/L; group 2). The primary end point was change in left
ventricular mass index (LVMI). Secondary end points included
echocardiographic variables, renal function, quality of life,
and safety. RESULTS: Median Hb level and LVMI were similar in
groups 1 and 2 (Hb, 11.9 and
12.7 g/dL [119 and 117 g/L]; LVMI, 113.5 and 112.3 g/m(2),
respectively). At study end, Hb levels were 13.5 g/dL (135
g/L) in group 1 and 12.1 g/dL (121 g/L) in group 2 (P <
0.001). No significant differences were observed in median
LVMI at month 15 between study groups (group 1, 112.3
g/m(2); group 2, 116.5 g/m(2)). Multivariate analysis
showed a nonsignificant decrease in LVMI (P =3D 0.15) in
group 1 versus group 2. Anemia correction had no effect on
the rate of decrease in creatinine clearance, but resulted
in significantly improved quality of life in group 1 (P =3D
0.04). There were no clinically relevant differences in
adverse events between study groups. CONCLUSION: In
patients with diabetes with mild to moderate anemia and
moderate left ventricular hypertrophy, correction to an Hb
target level of 13 to 15 g/dL (130 to 150 g/L) does not
decrease LVMI. However, normalization of Hb level prevented
an additional increase in left ventricular hypertrophy, was
safe, and improved quality of life.

PMID: 17261422 [PubMed - indexed for MEDLINE]

Who loves ya. Tom

Jesus Was A Vegetarian! http://jesuswasavegetarian.7h.com

Man Is A Herbivore! http://tinyurl.com/a3cc3

DEAD PEOPLE WALKING http://tinyurl.com/zk9fk

Ironjustic
Sat, Aug-18-07, 06:16
>> On Aug 17, 2:38 pm, "carwools" <carwo...@aol.com> wrote: no
>> care <<

You must not have any shares IN the .. company .. ?

I wonder why they went a 'wee' bit .. off label .. ? They MUST
have killed someone.

They said in the study they took them TO .. 15 g/dL and this
NeoRecormon label says **NOT** to go by ..13 g/dl .. ?

We found in the Choir Study THEY found people started
falling at 13.5
g/dL ..

Soooo .. this either PROVES their drug is SOOOO .. much ..
better .. obviously .. OR .. someone is hiding bodies .. ?

Sooo .. since they are not promoting THIS fact .. increased
survival .. then I would bet there ARE .. dead bodies around
somewhere.

Let's hope not .. because .. ? .. it was already known the
outcome of high hemoglobin in those with predialysis kidney
disease .. and THAT was .. ? .. death.

Soooo .. now .. I believe THESE guys for SURE knew the risks
of .. death .. and STILL continued IN their .. 'research' ..
dubious .. dubious .. 'research'.

"were randomly assigned to attain a target hemoglobin (Hb)
level of either 13 to 15 g/dL (130 to 150 g/L; group 1) or
10.5 to 11.5 g/dL (105 to 115 g/L; group 2)."

<<snip>> Treatment with NeoRecormon is initiated when
patients' haemoglobin level is 11 g/dl or below and given to
maintain a haemoglobin level of up to 13g/dl. <<snip>>

http://www.roche.com/med-cor-2007-01-10

Basel, 10 January 2007

NeoRecormon gains European approval for convenient once weekly
treatment of anaemia in patients with solid cancers

Roche announced today that it has received European marketing
approval for a simple and convenient once weekly subcutaneous
injection of NeoRecormon (epoetin beta) 30,000 IU for the
treatment of anaemia in patients with solid cancers receiving
chemotherapy. This expansion of the product label means that
patients will no longer have the burden of three injections
per week and their anaemia can be managed in a more
convenient way.

Anaemia affects up to 95% of cancer patients receiving
chemotherapy.1 It can develop as a result of the cancer itself
or as a consequence of its treatment. For most patients
anaemia manifests itself as an extreme and overwhelming
fatigue that makes the impact of cancer even more devastating.

NeoRecormon 30,000 IU once weekly is proven to effectively2
and rapidly3,4 correct anaemia irrespective of the type of
chemotherapy patients receive. It also reduces the need for
blood transfusions by at least 50% compared to standard
care5,6 and has been shown to significantly increase the time
until patients need a first transfusion.7 Patients treated
with NeoRecormon often experience an improvement in their
quality of life8 and an increase in their daily energy
levels.6,9

Key supportive data for the new label came from the BRAVE
(BReast cancer - Anaemia and the Value of Erythropoietin)
study, which was conducted in women with metastatic breast
cancer receiving chemotherapy5,7,10 and the NAUTICA study
conducted in patients with a wide range of cancer types also
receiving chemotherapy.3

About NeoRecormon NeoRecormon is prescribed for the treatment
of symptomatic anaemia in patients with cancer. Treating
anaemia increases red blood cell (haemoglobin) numbers and
oxygen levels allowing the body to function effectively, which
improves patients' quality of life and reduces morbidity.

NeoRecormon is one of Roche's leading biotechnology
achievements and market leader in the countries in which
it is sold.

With the label expansion announced today NeoRecormon 30,000
IU once weekly is now indicated for the treatment of
symptomatic anaemia in adult patients with solid and lymphoid
cancers receiving any form of chemotherapy. Treatment with
NeoRecormon is initiated when patients' haemoglobin level is
11 g/dl or below and given to maintain a haemoglobin level of
up to 13g/dl.

About Roche Headquartered in Basel, Switzerland, Roche is one
of the world's leading research-focused healthcare groups in
the fields of pharmaceuticals and diagnostics. As a supplier
of innovative products and services for the early detection,
prevention, diagnosis and treatment of disease, the Group
contributes on a broad range of fronts to improving people's
health and quality of life. Roche is a world leader in
diagnostics, the leading supplier of medicines for cancer and
transplantation and a market leader in virology. Roche employs
roughly 70,000 people in 150 countries and has R&D agreements
and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on
the Internet (www.roche.com).

All trademarks used or mentioned in this release are
protected by law.

References 1 Groopman & Itri. Natl Cancer Inst
1999;91:1616-34. 2 Leonard et al. Ann Oncol 2004; 15 (Suppl
3):iii 50 Abstract 188P. 3 Spa=EBth et al 2006; 17 (Suppl 9):
ix294 Abstract 1020P. 4 Boogaerts et al. Anticancer Res. 2006;
26:479-484. 5 Marangolo et al. Eur J Cancer Suppl 2005; 3: 388
Abstract 1347. 6 Ord=F3nez et al. Lung Cancer 2005; 49(Suppl
2): S339 Abstract P-836. 7 Aapro et al. 29th Annual San
Antonio Breast Cancer Symposium 2006; Poster 6095. 8 Boogaerts
et al. Br J Cancer 2003; 88: 988-995. 9 de Castro et al.
Cancer Chemother Pharmacol 2006; Jul 28 (Epub ahead of print).
10 Marangolo et al. Journal of Clinical Oncology 2005;23: 16S,
Part I of II: 8141.

NeoRecormon, an anti-anemia agent

Who loves ya. Tom

Jesus Was A Vegetarian! http://jesuswasavegetarian.7h.com

Man Is A Herbivore! http://tinyurl.com/a3cc3

DEAD PEOPLE WALKING http://tinyurl.com/zk9fk

<ironjust...@aol.com> wrote in message
>
> news:1187160612.239032.107620@x40g2000prg.googlegroups.com.-
> .. Anyone care to guess WHY there were NO .. deaths .. ?
> Where did they hide the bodies .. ? There HAD to be .. some
> .. bodies.
>
> The Acord Study seemed to be following the steps of the
> Procrit study in which Procrit had 33% increased .. death ..
> which has led to the veritable **demise** of .. Amgen ..
> Procrit was their .. lifeblood.
>
> NOW this Acord Study is completed .. using another epoetin
> .. BUT .. **noone** dies .. NO .. increased .. DEATH .. ?
>
> Same .. investigational target hemoglobin level of 13.5
> grams per deciliter of blood (g/dL).
>
> The Acord Study compared to the Choir Study. Choir
> Study:1,432 patients 72 died at 13.5 g/dL and 56 died at
> 11.3 g/ dL Acord Study:172 patients - 0? died at 13.5 g/dL
> and 0? died at 11.3 g/
> dL .. ? According to calculation: - 7 died at 13.5 g/dl and
> 5 died at 11.3 g/
> dl .. ?
>
> This would because of the small study .. and therefore
> any real ability to say .. "see" / not enough dead bodies
> TO count.
>
> Procrit made the mistake of BEING the brunt OF .. a .. large
> .. study.
>
> <<snip>> There were no clinically relevant differences in
> adverse events between study groups. {Acord Study } <<snip>>
>
> Two .. people .. not really significant .. multiply that by
> .. thousands ..
>
> BUSINESS/FINANCIAL DESK Heart Risk Seen in Drug For Anemia
> November 16, 2006 Health News By ALEX BERENSON A new study
> suggests that high doses of a best-selling drug used to
> treat anemia in dialysis and cancer patients may increase
> the risk of heart problems.
>
> --------------------------------------------
>
> Ortho Biotech Products, L.P. Release: Data From Correction
> Of Hemoglobin And Outcomes In Renal Insufficiency (CHOIR)
> Study Presented At National Kidney Foundation Meeting
>
> CHICAGO, April 20 /PRNewswire/ -- Final data from an
> investigational clinical trial, Correction of Hemoglobin and
> Outcomes in Renal Insufficiency, referred to as the CHOIR
> study, were presented today at the National Kidney
> Foundation (NKF) 2006 Spring Clinical Meetings.
>
> The primary analysis of the composite endpoint showed a
> statistically significant higher incidence of composite
> endpoint events -- consisting of mortality, stroke, heart
> attack and hospitalization due to congestive heart failure
> -- in the group of patients treated to the investigational
> hemoglobin target of 13.5 g/dL, as compared to the group
> treated to the hemoglobin target that is consistent with the
> current product label, 11.3 g/dL.
>
> One hundred and twenty-eight patients died during the study
> and the 90-day study follow-up period: 72 patients in the
> arm being treated to 13.5 g/dL and 56 patients in the arm
> being treated to 11.3 g/dL
>
> http://topics.nytimes.com/top/reference/timestopics/organiz-
> ations/h/h...
>
> The Anaemia CORrection in Diabetes (ACORD) study aims to
> investigate the effects of early anaemia correction with
> subcutaneous NeoRecormon=AE (epoetinbeta) on cardiac
> structure and function in patients with early diabetic
> nephropathy. The ACORD study is an international
> multicentre,randomised trial in which diabetic patients who
> are anaemic (Hb ? 10.5g/dl but less than 13g/dl) are
> assigned to one of two treatment groups. The early anaemia
> correction group start epoetinbeta therapy immediately to
> attain a target Hb level of 13-15g/ dl, while the late
> anaemia correction group only begin treatment once their Hb
> has declined below 10.5g/dl, with a target level of 10.5-
> 11.5g/dl. The results from the ACORD and IRIDIEM trials will
> provide additional information regarding the
> optimal management of anaemia and risk factors in
> patients with early diabetic nephropathy. Early
> referral and individualised intervention of
> patients with diabetic nephropathy is likely to be
> essential in order to minimise morbidity and
> mortality.
>
> <<snip>> There were no clinically relevant differences in
> adverse events between study groups. <<snip>>
>
> Am J Kidney Dis. 2007 Feb;49(2):194-207. Links Erratum in:
> Am J Kidney Dis. 2007 Apr;49(4):562. Target level for
> hemoglobin correction in patients with diabetes and CKD:
> primary results of the Anemia Correction in Diabetes (ACORD)
> Study.Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag
> A, Burger U, de Alvaro F; Anemia Correction in Diabetes
> Study Investigators. Department of Internal Medicine,
> University of Heidelberg; Medical Clinic I, University
> Hospital Mannheim, Germany. prof.e.ritz@t- online.de
>
> BACKGROUND: Patients with diabetes and anemia are at high
> risk of cardiovascular disease. The Anemia CORrection in
> Diabetes (ACORD) Study aimed to investigate the effect of
> anemia correction on cardiac structure, function, and
> outcomes in patients with diabetes with anemia and early
> diabetic nephropathy. METHODS: One hundred seventy-two
> patients with type 1 or 2 diabetes mellitus, mild to
> moderate anemia, and stage 1 to 3 chronic kidney disease
> were randomly assigned to attain a target hemoglobin (Hb)
> level of either 13 to 15 g/dL (130 to 150 g/L; group 1) or
> 10.5 to 11.5 g/dL (105 to 115 g/L; group 2). The primary
> end point was change in left ventricular mass index (LVMI).
> Secondary end points included echocardiographic variables,
> renal function, quality of life, and safety. RESULTS:
> Median Hb level and LVMI were similar in groups 1 and 2
> (Hb, 11.9 and
> 11.7 g/dL [119 and 117 g/L]; LVMI, 113.5 and 112.3 g/m(2),
> respectively). At study end, Hb levels were 13.5 g/dL
> (135 g/L) in group 1 and 12.1 g/dL (121 g/L) in group 2
> (P < 0.001). No significant differences were observed in
> median LVMI at month 15 between study groups (group 1,
> 112.3 g/m(2); group 2, 116.5 g/m(2)). Multivariate
> analysis showed a nonsignificant decrease in LVMI (P =3D
> 0.15) in group 1 versus group 2. Anemia correction had no
> effect on the rate of decrease in creatinine clearance,
> but resulted in significantly improved quality of life in
> group 1 (P =3D 0.04). There were no clinically relevant
> differences in adverse events between study groups.
> CONCLUSION: In patients with diabetes with mild to
> moderate anemia and moderate left ventricular
> hypertrophy, correction to an Hb target level of 13 to 15
> g/dL (130 to 150 g/L) does not decrease LVMI. However,
> normalization of Hb level prevented an additional
> increase in left ventricular hypertrophy, was safe, and
> improved quality of life.
>
> PMID: 17261422 [PubMed - indexed for MEDLINE]
>
> Who loves ya. Tom
>
> Jesus Was A Vegetarian!http://jesuswasavegetarian.7h.com
>
> Man Is A Herbivore!http://tinyurl.com/a3cc3
>
> DEAD PEOPLE WALKINGhttp://tinyurl.com/zk9fk

Dave
Sat, Aug-18-07, 06:16
OK.

I have been around since before Epogen. This is a bunch of
bluey. First off, any doctor that administers epogen past the
recommended upper limit of 12 Hemoglobin is commiting an act
that is tantemount to malpractice, and in the US, Medicare
will not pay for Epogen once Hemoglobin reaches 12. What
bothers me about this whole thing is that this drug is a
Miracle drug, and these studies pushing past the normally used
ranges is going to get the drug pulled from the market. Before
there was Epo, a patient would have to get blood transfusions,
sometimes as often as twice a week. Even with the blood
transfusions, you could barely walk across a room without
having to sit and rest. Used properly, this drug is safe. The
quality of life improvement provided by this drug is
unbelievable.

The same thing is happening here as happened with Vioxx
(?Spelling). The studies that got the medias panties in such a
knot were performed on patients who had existing heart
problems when they began to take the drug. The studies did
indeed show an increase in the risk of death in those
patients. However, there was never any scientific proof that
it caused damage to the hearts of those without pre-existing
heart disease. In fact, there are signs that can be readily
checked for that would indicate that the drug should be
stopped The media, and then the FDA, took a very narrow study
and extrapolated it to the general population, which is just
bad science. I can see the same thing happening here, and then
there will be no point to even offering dialysis, as patients
will not be able to live, just exist.

Now there are reasons why the limits were set at 12
Hemoglobin. For dialysis patients, it has to do with access
preservation. Higher levels have shown in studies to
significantly increase the risk of blood clots in the
access. In cancer patients, the problem has to do with the
chemotherapy drugs, which also can instigate a blood clot,
which in this case can cause strokes and/or heart attacks.
This is why these types of drugs need to be used
conservatively, with due diligence being done to monitor
the patient.

And No, I do not currently own any stock in either Amgen or J
& J, although I have owned both at one time or the other.

I am not saying these studies should be ignored, but there
needs to be further studies, especially in regards to those
that are maintained between 11-12 Hemoglobin, the normal range
for a dialysis patient.

Another example of what I am talking about is the fact that
extremely high use of the artificial sweetener saccharine has
been shown to cause cancer in rats. The fact is, they were
force feeding the rats amounts that would be equal to a human
eating fifty pounds (110 KG) of saccharine a day for years. I
doubt if there has even been one patient diagnosed with cancer
that could be traced to use of artificial sweeteners. All I am
saying here is that you have to look at the details of
studies, not the interpretation of the Media, which for all
intends and purposes, is scientifically illiterate. They
sensationalize everything in order to sell more papers or more
advertisements.

Well, I've vented enough on this subject for today.

Thanks,

Dave

"ironjustice@aol.com" <ironjustice@aol.com> wrote in
news:1187409141.521244.298840@m37g2000prh.googlegroups.com:

>>> On Aug 17, 2:38 pm, "carwools" <carwo...@aol.com> wrote:
>>> no care <<
>
> You must not have any shares IN the .. company .. ?
>
> I wonder why they went a 'wee' bit .. off label .. ? They
> MUST have killed someone.
>
> They said in the study they took them TO .. 15 g/dL and this
> NeoRecormon label says **NOT** to go by ..13 g/dl .. ?
>
> We found in the Choir Study THEY found people started
> falling at 13.5
> g/dL ..
>
> Soooo .. this either PROVES their drug is SOOOO .. much ..
> better .. obviously .. OR .. someone is hiding bodies .. ?
>
> Sooo .. since they are not promoting THIS fact .. increased
> survival .. then I would bet there ARE .. dead bodies around
> somewhere.
>
> Let's hope not .. because .. ? .. it was already known the
> outcome of high hemoglobin in those with predialysis kidney
> disease .. and THAT was .. ? .. death.
>
> Soooo .. now .. I believe THESE guys for SURE knew the risks
> of .. death .. and STILL continued IN their .. 'research' ..
> dubious .. dubious .. 'research'.
>
>
> "were randomly assigned to attain a target hemoglobin (Hb)
> level of either 13 to 15 g/dL (130 to 150 g/L; group 1) or
> 10.5 to 11.5 g/dL (105 to 115 g/L; group 2)."
>
> <<snip>> Treatment with NeoRecormon is initiated when
> patients' haemoglobin level is 11 g/dl or below and given to
> maintain a haemoglobin level of up to 13g/dl. <<snip>>
>
>
> http://www.roche.com/med-cor-2007-01-10
>
> Basel, 10 January 2007
>
> NeoRecormon gains European approval for convenient once
> weekly treatment of anaemia in patients with solid cancers
>
> Roche announced today that it has received European
> marketing approval for a simple and convenient once weekly
> subcutaneous injection of NeoRecormon (epoetin beta) 30,000
> IU for the treatment of anaemia in patients with solid
> cancers receiving chemotherapy. This expansion of the
> product label means that patients will no longer have the
> burden of three injections per week and their anaemia can be
> managed in a more convenient way.
>
> Anaemia affects up to 95% of cancer patients receiving
> chemotherapy.1 It can develop as a result of the cancer
> itself or as a consequence of its treatment. For most
> patients anaemia manifests itself as an extreme and
> overwhelming fatigue that makes the impact of cancer even
> more devastating.
>
> NeoRecormon 30,000 IU once weekly is proven to effectively2
> and rapidly3,4 correct anaemia irrespective of the type of
> chemotherapy patients receive. It also reduces the need for
> blood transfusions by at least 50% compared to standard
> care5,6 and has been shown to significantly increase the
> time until patients need a first transfusion.7 Patients
> treated with NeoRecormon often experience an improvement in
> their quality of life8 and an increase in their daily energy
> levels.6,9
>
> Key supportive data for the new label came from the BRAVE
> (BReast cancer - Anaemia and the Value of Erythropoietin)
> study, which was conducted in women with metastatic breast
> cancer receiving chemotherapy5,7,10 and the NAUTICA study
> conducted in patients with a wide range of cancer types also
> receiving chemotherapy.3
>
> About NeoRecormon NeoRecormon is prescribed for the
> treatment of symptomatic anaemia in patients with cancer.
> Treating anaemia increases red blood cell (haemoglobin)
> numbers and oxygen levels allowing the body to function
> effectively, which improves patients' quality of life and
> reduces morbidity.
>
> NeoRecormon is one of Roche's leading biotechnology
> achievements and market leader in the countries in which it
> is sold.
>
> With the label expansion announced today NeoRecormon 30,000
> IU once weekly is now indicated for the treatment of
> symptomatic anaemia in adult patients with solid and
> lymphoid cancers receiving any form of chemotherapy.
> Treatment with NeoRecormon is initiated when patients'
> haemoglobin level is 11 g/dl or below and given to maintain
> a haemoglobin level of up to 13g/dl.
>
> About Roche Headquartered in Basel, Switzerland, Roche is
> one of the world's leading research-focused healthcare
> groups in the fields of pharmaceuticals and diagnostics. As
> a supplier of innovative products and services for the early
> detection, prevention, diagnosis and treatment of disease,
> the Group contributes on a broad range of fronts to
> improving people's health and quality of life. Roche is a
> world leader in diagnostics, the leading supplier of
> medicines for cancer and transplantation and a market leader
> in virology. Roche employs roughly 70,000 people in 150
> countries and has R&D agreements and strategic alliances
> with numerous partners, including majority ownership
> interests in Genentech and Chugai. Additional information
> about the Roche Group is available on the Internet
> (www.roche.com).
>
> All trademarks used or mentioned in this release are
> protected by law.
>
>
> References 1 Groopman & Itri. Natl Cancer Inst
> 1999;91:1616-34. 2 Leonard et al. Ann Oncol 2004; 15 (Suppl
> 3):iii 50 Abstract 188P. 3 Spaëth et al 2006; 17 (Suppl 9):
> ix294 Abstract 1020P. 4 Boogaerts et al. Anticancer Res.
> 2006; 26:479-484. 5 Marangolo et al. Eur J Cancer Suppl
> 2005; 3: 388 Abstract 1347. 6 Ordónez et al. Lung Cancer
> 2005; 49(Suppl 2): S339 Abstract P-836. 7 Aapro et al. 29th
> Annual San Antonio Breast Cancer Symposium 2006; Poster
> 6095. 8 Boogaerts et al. Br J Cancer 2003; 88: 988-995. 9 de
> Castro et al. Cancer Chemother Pharmacol 2006; Jul 28 (Epub
> ahead of print). 10 Marangolo et al. Journal of Clinical
> Oncology 2005;23: 16S, Part I of II: 8141.
>
>
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> NeoRecormon, an anti-anemia agent
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> Who loves ya. Tom
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> Jesus Was A Vegetarian! http://jesuswasavegetarian.7h.com
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> Man Is A Herbivore! http://tinyurl.com/a3cc3
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> DEAD PEOPLE WALKING http://tinyurl.com/zk9fk
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> <ironjust...@aol.com> wrote in message
>>
>> news:1187160612.239032.107620@x40g2000prg.googlegroups.com-
>> ... Anyone care to guess WHY there were NO .. deaths .. ?
>> Where did they hide the bodies .. ? There HAD to be .. some
>> .. bodies.
>>
>> The Acord Study seemed to be following the steps of the
>> Procrit study in which Procrit had 33% increased .. death
>> .. which has led to the veritable **demise** of .. Amgen ..
>> Procrit was their .. lifeblood.
>>
>> NOW this Acord Study is completed .. using another epoetin
>> .. BUT .. **noone** dies .. NO .. increased .. DEATH .. ?
>>
>> Same .. investigational target hemoglobin level of 13.5
>> grams per deciliter of blood (g/dL).
>>
>> The Acord Study compared to the Choir Study. Choir
>> Study:1,432 patients 72 died at 13.5 g/dL and 56 died
>> at 11.3
g/
>> dL Acord Study:172 patients - 0? died at 13.5 g/dL and 0?
>> died at 11.3
h/
>> dL .. ? According to calculation: - 7 died at 13.5 g/dl and
>> 5 died at 11.3
i/
>> dl .. ?
>>
>> This would because of the small study .. and therefore
>> any real ability to say .. "see" / not enough dead bodies
>> TO count.
>>
>> Procrit made the mistake of BEING the brunt OF .. a ..
>> large ..
study.
>>
>> <<snip>> There were no clinically relevant differences in
>> adverse events between study groups. {Acord Study }
>> <<snip>>
>>
>> Two .. people .. not really significant .. multiply that by
>> .. thousands ..
>>
>> BUSINESS/FINANCIAL DESK Heart Risk Seen in Drug For Anemia
>> November 16, 2006 Health News By ALEX BERENSON A new study
>> suggests that high doses of a best-selling drug used to
>> treat anemia in dialysis and cancer patients may increase
>> the risk of heart problems.
>>
>> --------------------------------------------
>>
>> Ortho Biotech Products, L.P. Release: Data From Correction
>> Of Hemoglobin And Outcomes In Renal Insufficiency (CHOIR)
>> Study Presented At National Kidney Foundation Meeting
>>
>> CHICAGO, April 20 /PRNewswire/ -- Final data from an
>> investigational clinical trial, Correction of Hemoglobin
>> and Outcomes in Renal Insufficiency, referred to as the
>> CHOIR study, were presented today at the National Kidney
>> Foundation (NKF) 2006 Spring Clinical Meetings.
>>
>> The primary analysis of the composite endpoint showed a
>> statistically significant higher incidence of composite
>> endpoint events -- consisting of mortality, stroke, heart
>> attack and hospitalization due to congestive heart failure
>> -- in the group of patients treated to the investigational
>> hemoglobin target of 13.5 g/dL, as compared to the group
>> treated to the hemoglobin target that is consistent with
>> the current product label, 11.3 g/dL.
>>
>> One hundred and twenty-eight patients died during the study
>> and the 90-day study follow-up period: 72 patients in the
>> arm being treated to 13.5 g/dL and 56 patients in the arm
>> being treated to 11.3 g/dL
>>
>>
http://topics.nytimes.com/top/reference/timestopics/organizat-
ions/h/h...
>>
>> The Anaemia CORrection in Diabetes (ACORD) study aims to
>> investigate the effects of early anaemia correction with
>> subcutaneous
NeoRecormon®
>> (epoetinbeta) on cardiac structure and function in
>> patients with
early
>> diabetic nephropathy. The ACORD study is an international
>> multicentre,randomised trial in which diabetic patients who
>> are anaemic (Hb ? 10.5g/dl but less than 13g/dl) are
>> assigned to one of two treatment groups. The early anaemia
>> correction group start epoetinbeta therapy immediately to
>> attain a target Hb level of 13-
15g/
>> dl, while the late anaemia correction group only begin
>> treatment once their Hb has declined below 10.5g/dl, with a
>> target level of 10.5-
>> 11.5g/dl. The results from the ACORD and IRIDIEM trials
>> will provide additional information regarding the
>> optimal management of anaemia
and
>> risk factors in patients with early diabetic nephropathy.
>> Early referral and individualised intervention of patients
>> with diabetic nephropathy is likely to be essential in
>> order to minimise morbidity and mortality.
>>
>> <<snip>> There were no clinically relevant differences in
>> adverse events between study groups. <<snip>>
>>
>> Am J Kidney Dis. 2007 Feb;49(2):194-207. Links Erratum in:
>> Am J Kidney Dis. 2007 Apr;49(4):562. Target level for
>> hemoglobin correction in patients with diabetes and CKD:
>> primary results of the Anemia Correction in Diabetes
>> (ACORD) Study.Ritz E, Laville M, Bilous RW, O'Donoghue D,
>> Scherhag A, Burger U, de Alvaro F; Anemia Correction in
>> Diabetes Study Investigators. Department of Internal
>> Medicine, University of Heidelberg; Medical Clinic I,
>> University Hospital Mannheim, Germany. prof.e.ritz@t-
>> online.de
>>
>> BACKGROUND: Patients with diabetes and anemia are at high
>> risk of cardiovascular disease. The Anemia CORrection in
>> Diabetes (ACORD) Study aimed to investigate the effect of
>> anemia correction on cardiac structure, function, and
>> outcomes in patients with diabetes with anemia and
early
>> diabetic nephropathy. METHODS: One hundred seventy-two
>> patients with type 1 or 2 diabetes mellitus, mild to
>> moderate anemia, and stage 1 to 3 chronic kidney disease
>> were randomly assigned to attain a target hemoglobin (Hb)
>> level of either 13 to 15 g/dL (130 to 150 g/L; group 1) or
>> 10.5 to 11.5 g/dL (105 to 115 g/L; group 2). The primary
>> end point was change in left ventricular mass index (LVMI).
>> Secondary end points included echocardiographic variables,
>> renal function, quality of life, and safety. RESULTS:
>> Median Hb level and LVMI were similar in groups 1 and 2
>> (Hb, 11.9 and
>> 11.7 g/dL [119 and 117 g/L]; LVMI, 113.5 and 112.3 g/m(2),
>> respectively). At study end, Hb levels were 13.5 g/dL
>> (135 g/L) in group 1 and 12.1 g/dL (121 g/L) in group 2
>> (P < 0.001). No
significant
>> differences were observed in median LVMI at month 15
>> between study groups (group 1, 112.3 g/m(2); group 2, 116.5
>> g/m(2)). Multivariate analysis showed a nonsignificant
>> decrease in LVMI (P = 0.15) in group 1 versus group 2.
>> Anemia correction had no effect on the rate of decrease in
>> creatinine clearance, but resulted in significantly
>> improved quality of life in group 1 (P = 0.04). There were
>> no clinically relevant differences in adverse events
>> between study groups. CONCLUSION: In patients with diabetes
>> with mild to moderate anemia and moderate left ventricular
>> hypertrophy, correction to an Hb target level of 13 to 15
>> g/dL (130 to 150 g/L) does not decrease LVMI. However,
>> normalization of Hb level prevented an additional increase
>> in left ventricular hypertrophy, was safe, and improved
>> quality of life.
>>
>> PMID: 17261422 [PubMed - indexed for MEDLINE]
>>
>> Who loves ya. Tom
>>
>> Jesus Was A Vegetarian!http://jesuswasavegetarian.7h.com
>>
>> Man Is A Herbivore!http://tinyurl.com/a3cc3
>>
>> DEAD PEOPLE WALKINGhttp://tinyurl.com/zk9fk
>